[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100386151":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":59,"collaborators":20,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":20,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":20,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"TripleMed B.V.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Device: ANEUFIX",[13],"Device: Prophylactic sac filling with AneuFix",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Prophylactic sac filling with AneuFix","ANEUFIX is administered by injection into the AAA via transferal access at the time of EVAR placement using imaging techniques to guide the place of injection.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Arjan WJ Hoksbergen, Dr","VUmc Heelkunde, Amsterdam","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Florie Daniels","CONTACT","+31 6 38 19 92 91","f.daniels@triple-med.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Tjeerd Homsma","+31 6 29 07 80 03","t.homsma@triple-med.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"VUmc","RECRUITING","Amsterdam","North Holland","1081 HV","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],4.88969,52.37403,{"lat":49,"lon":48},[52,55],{"name":53,"role":29,"phone":20,"phoneExt":20,"email":54},"Arjan WJ Hoksbergen, Dr.","a.hoksbergen@amsterdamumc.nl",{"name":56,"role":29,"phone":57,"phoneExt":20,"email":58},"Stefan Smorenburg","+31 6 22 61 28 62","s.smorenburg@amsterdamumc.nl",{"type":60,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100386151","aneufix---prophylactic-sac-filling-100386151",false,"NCT04307992","AneuFix - Prophylactic Sac Filling","Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation","Inclusion Criteria:\n\n* Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al:\n\n  \\- Open IMA AND\n  * 1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) \\>17,5cm2 OR\n  * 2 patent lumbars AND a CSAIMA \\>15cm2 OR\n  * 3 patent lumbars AND a CSAIMA \\>12,5 cm2 OR\n  * 4 patent lumbars AND a CSAIMA \\>10 cm2 OR\n  * 5 patent lumbars AND a CSAIMA \\>7,5 cm2\n* Infrarenal neck according to the IFU of the EVAR device\n* Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used\n* Patient having a life expectation of at least 2 years\n* Being older than 18 years\n* Willing and able to comply with the requirements of this clinical study\n\nExclusion Criteria:\n\n* Patient not able or willing to give written Informed Consent\n* Patient undergoing emergency procedures\n* Patient undergoing EVAR for ruptured or symptomatic AAA,\n* Patient with a suprarenal AAA\n* Patient with an inflammatory AAA (more than minimal wall thickening)\n* Patient with an infrarenal neck unsuitable for endovascular fixation (including so called \"hostile necks\") or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used\n* Patient in which a bilateral retroperitoneal incision is required for EVAR\n* Patient in which a sacrifice of both hypogastric arteries is required\n* Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation\n* Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent\n* Patient with active infection present\n* Patients scheduled for or having received an organ transplant\n* Patient with limited life expectation due to other illness (\\\u003C1 year)\n* Patient with non-iatrogenic bleeding diathesis\n* Patient with connective tissue disease\n* Women of child-bearing potential\n* Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation","ALL","18 Years",{"count":71,"type":72},5,"ESTIMATED","INTERVENTIONAL",[75],"NA","This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.",[78,79],"Abdominal Aortic Aneurysm","Endoleak","2024-06-06",{"date":82,"type":83},"2024-06-07","ACTUAL",{"date":85,"type":83},"2022-02-15",{"date":87,"type":72},"2025-12-31",{"name":5,"class":6},1]